Five-Year Observation of Remicade Treatment for Plaque Psoriasis in Austria (Study P04900)
2015年7月15日 更新者：Merck Sharp & Dohme LLC
Real Life Treatment Regimen of Remicade (Infliximab) in Austria, Monitored Over 5 Years in Plaque Psoriasis Therapy
Prospective, open-label-, 1-arm, multicenter observational study to determine the dose and interval of Infliximab infusions for subjects with plaque psoriasis.
研究概览
详细说明
This study population was chosen from a non-probability sample.
研究类型
观察性的
注册 (实际的)
26
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Adult subjects with moderate-to-severe plaque psoriasis will receive Infliximab induction therapy in specialized centers.
描述
Inclusion Criteria:
- According to the European Summary of Product Characteristics (SPC): Adult subjects with moderate-to-severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systematic therapy including cyclosporine, methotrexate, or Psoralen-ultraviolet-A light (PUVA).
Exclusion Criteria:
According to the European SPC:
- Subjects with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections.
- Subjects with moderate-to-severe heart failure (New York Heart Association (NYHA) class III/IV).
- Subjects with a history of hypersensitivity to Infliximab or to other murine proteins or to any of the excipients.
- Subjects with elevated liver enzymes (>5 upper limit of normal (ULN)).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Infliximab
Subjects with plaque psoriasis will receive Infliximab initial induction therapy consisting of 3 Infliximab infusions at weeks 0, 2, and 6 given in specialized centers.
A maximum of 6 maintenance infusions will be given in doses and intervals due to the discretion of the physicians.
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Infliximab initial induction therapy consisting of 3 Infliximab infusions at weeks 0, 2, and 6 given in specialized centers.
A maximum of 6 maintenance infusions will be given in doses and intervals due to the discretion of the physicians.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab
大体时间：Maximum 2 years
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The types of therapies were assessed according to the following criteria: Induction therapy: first infusion given at Week 0 (Baseline). Second infusion given at Week 2 (+/- 7 days). Third infusion given at Week 6 (+/- 7 days). Maintenance therapy: given in approximately 8-week (56-day) intervals (time window +4 weeks to -2 weeks). One infusion given out of the time window was accepted to be classified as maintenance therapy, if the remaining infusions were given within the time window (8 weeks, +4 to -2 weeks). Episodic Therapy: given out of time frame (> 12 weeks). |
Maximum 2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy
大体时间：Maximum 2 years
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Maximum 2 years
|
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Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy
大体时间：Maximum 2 years
|
Maximum 2 years
|
|
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Mean Dose of Infliximab
大体时间：Maximum 2 years
|
Maximum 2 years
|
|
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Median Dose of Infliximab
大体时间：Maximum 2 years
|
Maximum 2 years
|
|
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Mean Percent Change From Baseline in Body Surface Area (BSA) Involved With Psoriasis After Treatment With Infliximab
大体时间：Baseline and Infusion 9
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BSA estimation was determined using the participant's handprint (palmar surface of palms plus five digits).
The number of handprints that covered the affected skin area was counted.
One handprint was approximately equivalent to 1 percent of the BSA; therefore, BSA was calculated in percentages.
The change from Baseline in BSA was calculated by subtracting Baseline from infusion 9.
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Baseline and Infusion 9
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2006年10月1日
初级完成 (实际的)
2010年6月1日
研究完成 (实际的)
2010年6月1日
研究注册日期
首次提交
2008年7月25日
首先提交符合 QC 标准的
2008年7月25日
首次发布 (估计)
2008年7月30日
研究记录更新
最后更新发布 (估计)
2015年7月28日
上次提交的符合 QC 标准的更新
2015年7月15日
最后验证
2015年7月1日
更多信息
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